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We will respond to you as soon as possible. 
 
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London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
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The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Matt Cooper
<[FOI #832830 email]> Sent: Sunday, February 13,
2022 12:56:30 AM To: MHRA Customer Services Subject: Freedom of
Information request - Analytical methods used in batch testing COVID-19
vaccines Dear Medicines and Healthcare Products Regulatory Agency, This
request relates to analytical techniques used by MHRA/NIBSC relating to
independent analysis of COVID-19 vaccines. As you are aware, laboratories
around the world have found contaminants including, but not limited to: -
Graphene and its associated compounds - Iron oxide - Martenistic stainless
steel - Calcium Carbonate - Glass My questions are as follows: 1) Given
that you are aware, or ought to be aware of said contaminants, what
techniques are used in routine batch testing which would detect these
before distribution? Please provide raw data for a non-conforming vial. 2)
Given that many of these contaminants are mictoscopic, non-biocompatible
and could cause harm if injected, is a microscope and directional lighting
used in the visual inspection process? 3) How many vials of COVID-19
vaccines have been rejected due to particulate contamination: a) By
MHRA/NIBSC prior to distribution? b) By healthcare professionals? c) Of
the number in b), how many were "passed" by MHRA/NIBSC? d) Please release
details of CAPA processes relating to nonconformances. 4) Please detail
the methods by which MHRA/NIBSC investigate nonconformant vials discovered
by: a) MHRA/NIBSC prior to distribution. b) Healthcare professionals
post-distribution. 5) Do MHRA/NIBSC have access to any of the following
analytical methods? if so, provide details on any applicable excitation
source(s), resolution and sensitivity of the equipment. - Mass
spectrometry - Chromatography - Raman spectroscopy - X-ray photoelectron
spectroscopy - X-ray energy-dispersive spectroscopy - Optical microscopy -
Electron microscopy - Scanning Auger microscopy Please also provide any
other analytical methods used by MHRA/NIBSC used to independently verify
nonconformances, and also routine quality and safety testing. Yours
faithfully, Matt Cooper
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #832830 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
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Please note that in some cases publication of requests and responses will
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show quoted sections

Our Ref: FOI 22/465

Dear Matt Cooper,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 14th February 2022.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections

FOI 22/465
 
Dear Mr Cooper,
 
Thank you for your information request, dated 13th February 2022, where
you asked for information related to analytical techniques used by
MHRA/NIBSC relating to independent analysis of COVID-19 vaccines, and with
particular reference to contaminants identified by laboratories around the
world, including, but not limited to:
 
- Graphene and its associated compounds
- Iron oxide
- Martenistic stainless steel
- Calcium Carbonate
- Glass.
 
I am pleased to provide you with the information requested, see below. A
response is provided following each of your questions.
 
1) Given that you are aware, or ought to be aware of said contaminants,
what techniques are used in routine batch testing which would detect these
before distribution? Please provide raw data for a non-conforming vial.
 
Tests for such materials are not undertaken in Independent batch release
testing. The types of tests performed are indicated on the NIBSC website:
[1]https://nibsc.org/control_testing.aspx
 
2) Given that many of these contaminants are mictoscopic,
non-biocompatible and could cause harm if injected, is a microscope and
directional lighting used in the visual inspection process?
 
The visual inspection is performed by eye and to European Pharmacopoeia
(EP) monographs. It is a review against two monochrome backgrounds to
observe particulate matter visible to the naked eye.
 
3) How many vials of COVID-19 vaccines have been rejected due to
particulate contamination:
 
a) By MHRA/NIBSC prior to distribution?
 
Independent batch release testing does not test every vial of a batch and
thus the rejection of individual vials does not occur. Vials
representative of the batch are tested.
 
b) By healthcare professionals?
 
NIBSC would not hold this information.
 
c) Of the number in b), how many were "passed" by MHRA/NIBSC?
 
Healthcare professionals would only receive batches of vaccine passed by
MHRA/NIBSC. As described above, a full batch is sampled and passed, not
individual vials.
 
d) Please release details of CAPA processes relating to nonconformances.
 
All of our product testing is undertaken to ISO 17025 compliance under our
externally assessed UK Accreditation Service (UKAS) ISO 17025 accredited
Quality Management System and a CAPA process is included in this Quality
Management system. Any product testing that fails the specified criteria
will not be issued for use.
 
4) Please detail the methods by which MHRA/NIBSC investigate nonconformant
vials discovered by:
 

 1. MHRA/NIBSC prior to distribution.

 
Non-conformant batches are not issued for use. Individual vials are not
certificated. A manufacturer will be informed of a failed batch.
 

 2. Healthcare professionals post-distribution.

 
NIBSC is not requested to carry out any post-distribution testing by
healthcare professionals.
 
5) Do MHRA/NIBSC have access to any of the following analytical methods?
if so, provide details on any applicable excitation source(s), resolution
and sensitivity of the equipment.
 
- Mass spectrometry
- Chromatography
- Raman spectroscopy
- X-ray photoelectron spectroscopy
- X-ray energy-dispersive spectroscopy
- Optical microscopy
- Electron microscopy
- Scanning Auger microscopy
 
MHRA/NIBSC does have access to some of the analytical methods listed.
Details of analytical science facilities available in NIBSC are provided
at  [2]https://nibsc.org/science_and_research/a...
They are not used in the assessment of COVID-19 vaccines, other than
optical microscopy that is used for some potency assays.
 
Please also provide any other analytical methods used by MHRA/NIBSC used
to independently verify nonconformances, and also routine quality and
safety testing.
 
Independent batch release testing includes a range of techniques specific
to the product and includes a range of visual, molecular, serological,
cell-based tests to confirm identity of material, potency, integrity
[3]https://nibsc.org/control_testing/batch-...
 
 
The Freedom of Information Act only entitles you access to information –
the information supplied is subject to Crown copyright, and there are some
restrictions on its re-use. For information on the reproduction or re-use
of MHRA information, please visit
[4]https://www.gov.uk/government/publicatio....
 
 
If you have a query about the information provided, please reply to this
email.
 
Please remember to quote the reference number above in any future
communications.
 
If you were to remain dissatisfied with the outcome of the internal
review, you would have the right to apply directly to the Information
Commissioner for a decision. Please bear in mind that the Information
Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review. The Information
Commissioner can be contacted at:
 
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
 
Yours sincerely
 
 
 
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
 
 

show quoted sections

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Matt Cooper
<[FOI #832830 email]> Sent: Sunday, March 13, 2022
2:27:48 AM To: MHRA Customer Services Subject: Re: FOI 22/465 - Freedom of
Information request - Analytical methods used in batch testing COVID-19
vaccines Dear MHRA Customer Services, Thank you for the information. I
would like to ask a simple follow-up, as you have made it clear that
batches, not vials are a "unit" as far as QA is concerned. How many
batches have been rejected? How many times has a manfacturer been notified
of a failed batch? Yours sincerely, Matt Cooper

show quoted sections

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Matt Cooper
<[FOI #832830 email]> Sent: Sunday, March 13, 2022
2:27:48 AM To: MHRA Customer Services Subject: WITH YVONNE - Re: FOI
22/465 - Freedom of Information request - Analytical methods used in batch
testing COVID-19 vaccines Dear MHRA Customer Services, Thank you for the
information. I would like to ask a simple follow-up, as you have made it
clear that batches, not vials are a "unit" as far as QA is concerned. How
many batches have been rejected? How many times has a manfacturer been
notified of a failed batch? Yours sincerely, Matt Cooper -----Original
Message----- FOI 22/465 Dear Mr Cooper, Thank you for your information
request, dated 13th February 2022, where you asked for information related
to analytical techniques used by MHRA/NIBSC relating to independent
analysis of COVID-19 vaccines, and with particular reference to
contaminants identified by laboratories around the world, including, but
not limited to: - Graphene and its associated compounds - Iron oxide -
Martenistic stainless steel - Calcium Carbonate - Glass. I am pleased to
provide you with the information requested, see below. A response is
provided following each of your questions. 1) Given that you are aware, or
ought to be aware of said contaminants, what techniques are used in
routine batch testing which would detect these before distribution? Please
provide raw data for a non-conforming vial. Tests for such materials are
not undertaken in Independent batch release testing. The types of tests
performed are indicated on the NIBSC website:
[1]https://eur01.safelinks.protection.outlo...
2) Given that many of these contaminants are mictoscopic,
non-biocompatible and could cause harm if injected, is a microscope and
directional lighting used in the visual inspection process? The visual
inspection is performed by eye and to European Pharmacopoeia (EP)
monographs. It is a review against two monochrome backgrounds to observe
particulate matter visible to the naked eye. 3) How many vials of COVID-19
vaccines have been rejected due to particulate contamination: a) By
MHRA/NIBSC prior to distribution? Independent batch release testing does
not test every vial of a batch and thus the rejection of individual vials
does not occur. Vials representative of the batch are tested. b) By
healthcare professionals? NIBSC would not hold this information. c) Of the
number in b), how many were "passed" by MHRA/NIBSC? Healthcare
professionals would only receive batches of vaccine passed by MHRA/NIBSC.
As described above, a full batch is sampled and passed, not individual
vials. d) Please release details of CAPA processes relating to
nonconformances. All of our product testing is undertaken to ISO 17025
compliance under our externally assessed UK Accreditation Service (UKAS)
ISO 17025 accredited Quality Management System and a CAPA process is
included in this Quality Management system. Any product testing that fails
the specified criteria will not be issued for use. 4) Please detail the
methods by which MHRA/NIBSC investigate nonconformant vials discovered by:
1. MHRA/NIBSC prior to distribution. Non-conformant batches are not issued
for use. Individual vials are not certificated. A manufacturer will be
informed of a failed batch. 2. Healthcare professionals post-distribution.
NIBSC is not requested to carry out any post-distribution testing by
healthcare professionals. 5) Do MHRA/NIBSC have access to any of the
following analytical methods? if so, provide details on any applicable
excitation source(s), resolution and sensitivity of the equipment. - Mass
spectrometry - Chromatography - Raman spectroscopy - X-ray photoelectron
spectroscopy - X-ray energy-dispersive spectroscopy - Optical microscopy -
Electron microscopy - Scanning Auger microscopy MHRA/NIBSC does have
access to some of the analytical methods listed. Details of analytical
science facilities available in NIBSC are provided at
[2]https://eur01.safelinks.protection.outlo...
They are not used in the assessment of COVID-19 vaccines, other than
optical microscopy that is used for some potency assays. Please also
provide any other analytical methods used by MHRA/NIBSC used to
independently verify nonconformances, and also routine quality and safety
testing. Independent batch release testing includes a range of techniques
specific to the product and includes a range of visual, molecular,
serological, cell-based tests to confirm identity of material, potency,
integrity
[3]https://eur01.safelinks.protection.outlo...
The Freedom of Information Act only entitles you access to information –
the information supplied is subject to Crown copyright, and there are some
restrictions on its re-use. For information on the reproduction or re-use
of MHRA information, please visit
[4]https://eur01.safelinks.protection.outlo....
If you have a query about the information provided, please reply to this
email. Please remember to quote the reference number above in any future
communications. If you were to remain dissatisfied with the outcome of the
internal review, you would have the right to apply directly to the
Information Commissioner for a decision. Please bear in mind that the
Information Commissioner will not normally review our handling of your
request unless you have first contacted us to conduct an internal review.
The Information Commissioner can be contacted at: Information
Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF
Yours sincerely MHRA Customer Experience Centre Communications and
engagement team Medicines and Healthcare products Regulatory Agency 10
South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #832830 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

FOI 22/554
 
Dear Mr Cooper
Thank you for your information request, dated 13th March 2022, where you
asked a follow-up question to FOI 22/465 in relation to batch testing of
COVID-19 vaccines:
 
How many batches have been rejected?
 
How many times has a manufacturer been notified of a failed batch?
 
I am pleased to provide you with the information requested.
 
We have obtained out of specification results for an individual test for
two batches of a vaccine. The relevant manufacturer was notified on each
occasion. In each case, the manufacturer withdrew their request for
release of the batch and it was not necessary for NIBSC to formally reject
the batch.
 
I hope this answers your question.
 
 
Yours sincerely
 
 
 
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
 

show quoted sections